Citalopram for Agitation in Alzheimer's Disease (CitAD)

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Recruitment activities included chart review, telephone interviews and screens, discussion with physicians, and recruitment in the clinic waiting areas and assisted living facilities affiliated with the clinics. The recruitment period lasted from August 2009 to December 2012.

Pre-assignment Details

Arm/Group Title

Citalopram and Psychosocial Intervention

Placebo and Psychosocial Intervention

Arm/Group Description

Target dose of 30 mg per day of cit...

Matching placebo, oral, and psychos...

Arm/Group Description

Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention

NeuroBehavioral Rating Scale- Agitation(NBRS-A) assesses multiple types of psychopathology common in dementia and is based on a seven point Likert scale of increasing severity for each item(i.e., 0=not present, 1=very mild, 2-mild, 3=moderate, 4=moderately severe, 5=severe, 6=extremely severe). The NBRS agitation subscore includes NBRS 'inhibition’, ‘agitation’, and ‘hostility’. The range is 0 to 18 points. Higher scores indicate more symptoms.

Time Frame

9 weeks

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

The primary analysis was an intention-to-treat analysis; analysis was conducted "as randomized". Data from the 186 randomized participants were used in the analytic model. 167 of the 186 patients had week 9 data on the NBRS.

Arm/Group Title

Citalopram and Psychosocial Intervention

Placebo and Psychosocial Intervention

Arm/Group Description:

Target dose of 30 mg per day of cit...

Matching placebo, oral, and psychos...

Arm/Group Description:

Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention

Primary assessment of efficacy was based on intention-to-treat comparison of the difference in the NBRS-A scores at week 9 and comparison at week 9 for the CGIC. For the NBRS-A, the study was designed to have 85% power to detect a standardized difference at week 9 of 40% for citalopram compared to placebo at week 9.

Type of
Statistical Test

Superiority or Other

Comments

[Not Specified]

Statistical Test of Hypothesis

P-Value

0.036

Comments

P-value was not adjusted for multiple comparisons. All p-values are two-sided and p<0.05 was the threshold for statistical significance.

Modified Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change in agitation(CGIC) accesses clinically significant change in agitation. A trained clinician, blind to treatment assignment, uses a 7-point Likert scale to rate change of each patient along a continuum from “marked improvement”(1), “no change”(4), and “marked worsening”(7). A number of aspects of the agitation is considered such as emotional agitation, mood liability/distress, psychomotor agitation, verbal aggression, and physical aggression. Range is 1-7.

Time Frame

Baseline to 9 weeks

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

The primary analysis was an intention-to-treat analysis; analysis was conducted "as randomized". Data from the 186 randomized participants were used in the analytic model. 167 of the 186 patients had week 9 data on CGIC.

Arm/Group Title

Citalopram and Psychosocial Intervention

Placebo and Psychosocial Intervention

Arm/Group Description:

Target dose of 30 mg per day of cit...

Matching placebo, oral, and psychos...

Arm/Group Description:

Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention

Primary assessment of efficacy was based on intention-to-treat comparison of the difference in the NBRS-A scores at week 9 and comparison at week 9 for the CGIC. For the CGIC proportional odds analysis, the study was designed to have power greater than 80% to detect a difference of 20% between citalopram and placebo in the proportions of patients who improve (or worsen).

Type of
Statistical Test

Superiority or Other

Comments

[Not Specified]

Statistical Test of Hypothesis

P-Value

0.007

Comments

All p-values are two-sided and p <0.05 was the threshold for statistical significance. No adjustments were made for multiple comparisons.

The primary analysis was an intention-to-treat analysis; analysis was conducted "as randomized". Data from the 186 randomized participants were used in the analytic model. 169 of the 186 patients had week 9 data.

Arm/Group Title

Citalopram and Psychosocial Intervention

Placebo and Psychosocial Intervention

Arm/Group Description:

Target dose of 30 mg per day of cit...

Matching placebo, oral, and psychos...

Arm/Group Description:

Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention

citalopram : target dose 30mg daily for 9 weeks

Matching placebo, oral, and psychosocial intervention

placebo : daily for 9 weeks

Overall Number of Participants Analyzed

90

85

Mean (Standard Deviation)

Unit of Measure: units on a scale

27.7
(6.7)

28.7
(6.7)

4.Secondary Outcome

Title

Neuropsychiatric Inventory (NPI)-- Agitation Subscore

Description

NPI agitation score is based on responses from an informed caregiver i...

Description

NPI agitation score is based on responses from an informed caregiver involved in the patient's life. Symptom severity (1=mild, 2=moderate, 3=severe) is multiplied by frequency (1=occasionally, less than once/week; 4 = very frequently, once or more/day or continuously) to obtain the NPI agitation score.Range is 0-12. Higher scores indicate more severe symptoms.

Time Frame

9 weeks

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

The primary analysis was an intention-to-treat analysis; analysis was conducted "as randomized". Data from the 186 randomized participants were used in the analytic model. 169 of the 186 patients had week 9 data.

Arm/Group Title

Citalopram and Psychosocial Intervention

Placebo and Psychosocial Intervention

Arm/Group Description:

Target dose of 30 mg per day of cit...

Matching placebo, oral, and psychos...

Arm/Group Description:

Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention

Adverse events (AEs) are collected systematically on the follow-up visit form; therefore, numbers of participants at risk for AEs reflect at least on follow-up visit form completed. Serious adverse events are often self-reported and can be collected any time throughout the study.

Arm/Group Title

Citalopram and Psychosocial Intervention

Placebo and Psychosocial Intervention

Arm/Group Description

Target dose of 30 mg per day of cit...

Matching placebo, oral, and psychos...

Arm/Group Description

Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention

citalopram : target dose 30mg daily for 9 weeks

Matching placebo, oral, and psychosocial intervention

placebo : daily for 9 weeks

All-Cause Mortality

Citalopram and Psychosocial Intervention

Placebo and Psychosocial Intervention

Affected / at Risk (%)

Affected / at Risk (%)

Total

--/--

--/--

Serious Adverse Events Serious Adverse Events

Citalopram and Psychosocial Intervention

Placebo and Psychosocial Intervention

Affected / at Risk (%)

Affected / at Risk (%)

Total

8/94 (8.51%)

7/92 (7.61%)

Cardiac disorders

Hypotension *

1/94 (1.06%)

0/92 (0.00%)

Chest pain *

1/94 (1.06%)

0/92 (0.00%)

Infections and infestations

Sepsis *

1/94 (1.06%)

0/92 (0.00%)

Surgical removal of infected plate in wrist *

1/94 (1.06%)

0/92 (0.00%)

Musculoskeletal and connective tissue disorders

Abdominal pain *

0/94 (0.00%)

1/92 (1.09%)

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung cancer *

0/94 (0.00%)

1/92 (1.09%)

Nervous system disorders

Fall *

1/94 (1.06%)

1/92 (1.09%)

Psychiatric disorders

Mental status change *

1/94 (1.06%)

2/92 (2.17%)

Increased agitation *

1/94 (1.06%)

2/92 (2.17%)

Respiratory, thoracic and mediastinal disorders

Pneumonia *

1/94 (1.06%)

0/92 (0.00%)

*

Indicates events were collected by non-systematic assessment

Other (Not Including Serious) Adverse Events Other (Not Including Serious) Adverse Events